Catheter assemblies are a good option for many users who suffer from various abnormalities of the urinary system. A common situation is where single use, individually packaged, sterile ready-to-use catheters are utilized. An important criterion for single use, ready-to-use products is that they be entirely user-friendly upon removal from the packaging.
It is quite common for single use, ready-to-use catheters to be provided with a surface treatment which uses a lubricant adapted to reduce friction in order to allow for easier and less traumatic catheter insertion. Currently, there are two major categories of catheters having lubricated surfaces, i.e., so-called “gel-lubricated catheters,” having a lubricant applied to the catheter shaft, and catheters having a hydrated hydrophilic outer surface on the catheter shaft.
In a hydrophilic lubricated catheter, the catheter is typically provided with a thin hydrophilic coating adhered to the outer surface of the catheter shaft. Hydrophilic lubricated catheters are activated when a hydrating agent such as water comes into direct contact with the hydrophilic coating on the catheter shaft. When this hydrophilic coating is activated, it provides a low coefficient-of-friction surface to facilitate catheter insertion.
When a catheter is removed from the package for insertion into the urethra, there are some disadvantages encountered. First, when the proximal insertion end of the catheter is introduced into the urethra it may pick up pathogens that are likely to be prevalent in the distal portion of the urethra. These pathogens are then often carried by the proximal insertion end of the catheter into the bladder as it is fully inserted, thereby possibly increasing the risk of infection. Second, the handling of the catheter by the user may also introduce microorganisms onto the surface of the catheter which can cause infection after catheter insertion. For hydrophilic lubricated catheters, these issues must be solved without interfering with activation of the hydrophilic outer surface.
Specifically, for a hydrophilic lubricated catheter, any attempt to: i) prevent pathogens from being picked up by the proximal insertion end of the catheter upon introduction into the distal portion of the urethra, and ii) prevent the introduction of microorganisms onto the surface of the catheter as a result of handling by the user, must be addressed in a manner that does not interfere with the hydrating agent coming into direct contact with the hydrophilic outer surface.
For hydrophilic lubricated catheters, sleeves covering the catheter shaft have not been widely available for a variety of reasons. When they have been provided to protect against contamination from handling of the catheter by the user, they still have failed to remedy the problem of the proximal insertion end picking up pathogens when passing through the distal portion of the urethra during catheter insertion. To address the latter problem, the catheter may be provided with an introducer tip to allow the catheter to bypass the distal portion of the urethra.
While this tends to protect against the delivery of pathogens from the distal portion of the urethra into the bladder, some users have an apprehension about inserting an introducer tip into the urethra during catheterization due to its size. In addition, introducer tips typically have required providing a lubricating gel in the region of the introducer tip as the introducer tip does not typically have a hydrophilic surface, and to ensure there is adequate lubrication of the proximal insertion end of the catheter shaft because, due to its size and material, the introducer tip may inhibit the ability of the hydrating agent to reach the hydrophilic outer surface on the catheter shaft. Thus, there remains a need for a new mechanism to adequately protect the user against delivery of pathogens into the distal portion of the urethra into the bladder without apprehension and with little or no recognition of its existence by the user.